Recall of Edwards EVOQUE Tricuspid Delivery System

Source: Health Canada · Canada

Areazine synthesizes this Health Canada recall directly from Health Canada's official public data feed. See our methodology for full source attribution and refresh cadence.

Health Canada has announced a voluntary recall for the Edwards EVOQUE Tricuspid Delivery System due to a labeling issue, requiring an update to ensure proper use.

What this Health Canada recall tells you, and what most readers miss

This notice was issued by Health Canada on April 2, 2026 and geographically references Canada. Its severity classification of "low" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - Product & Food Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.

Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, health-canada, MedicalDevice.

What Happened

Edwards Lifesciences is notifying customers of a voluntary recall involving a labeling update for the Edwards EVOQUE Tricuspid Delivery System. This correction aims to support proper use of the device and ensure optimal performance, and it does not require product return.

Which Products Are Affected

The affected product is the Edwards EVOQUE Tricuspid Delivery System, covering all lots, with the model or catalogue number 9850TDS. No specific quantities, UPCs, or date ranges were provided.

What You Should Do

Consumers should be aware of the labeling update and can contact Edwards Lifesciences LLC for more information. No product return is necessary as this is a labeling correction.

Why This Matters

This recall matters because correcting the labeling helps ensure the device is used correctly, potentially maintaining its effectiveness and safety for users.

Source

This information is from Health Canada. For more details, visit https://recalls-rappels.canada.ca/en/alert-recall/edwards-evoque-tricuspid-delivery-system.

Original source: Health Canada Official Notice ↗

All Product & Food Recalls →

Nationwide notices with similar length or severity timing 8

Two Areazine-derived peer sets for this Health Canada recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.

Frequently Asked Questions

Common questions about this Health Canada recall.

What is this Health Canada recall about?
Health Canada has announced a voluntary recall for the Edwards EVOQUE Tricuspid Delivery System due to a labeling issue, requiring an update to ensure proper use.
Which agency issued this alert?
This alert was issued by Health Canada. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "low" severity. No immediate action required, but stay aware.
What area is affected?
This alert affects Canada. Check with Health Canada for the most current geographic scope.
Where can I find more Product & Food Recalls updates?
Browse the full Product & Food Recalls feed on Areazine at areazine.com/ca/recalls/ for the latest updates from Health Canada and other agencies.